24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OBC BONE ANCHORED HEARING SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
3900 3 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750008018·3900A STPCK 3WAY Y SHP 22MMOD
FX V135
FDA UDI
FX SOLUTIONS·03701037321027·M GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100530·Caddie, 7.5mm Screws
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450613108·
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981063252·CROSSBAR, MEDIUM, 5.5 ROD
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
FDA 510(k)
FDA Class 1
·Dental
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30, SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235403·Adjustable Drill Size Ø4.0 mm
BIPAP A30
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code MNS·September 13, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·September 4, 2020
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024